Chemical, physical, and in vitro characterization of research cigarettes containing denicotinized tobacco

Regulatory Toxicology and Pharmacology

Volumn 79, Issue , 2016, Pages 64-73

  Coffa, Bonnie G ^a   Coggins, Christopher R E ^b   Werley, Michael S ^a   Oldham, Michael J ^a   Fariss, Marc W ^a  

^a Altria Client Services   (United States)

^b Carson Watts Consulting   (United States)

Author keywords

Denic; Denicotinized tobacco; Reduced nicotine content cigarettes; Tobacco constituents; Very low nicotine tobacco

Indexed keywords

ALIPHATIC COMPOUND; ALIPHATIC HYDROCARBON; AROMATIC AMINE; CARBON DIOXIDE; FORMALDEHYDE; HALOGEN; METAL; NICOTINE; NITROGEN DERIVATIVE; NITROSAMINE; PHENOL; BACTERIAL DNA; NICOTINIC AGENT; SMOKE;

ARTICLE; BIOLOGICAL ACTIVITY; CHEMICAL COMPOSITION; CHEMICAL PARAMETERS; CYTOTOXICITY; DENICOTINIZED TOBACCO; IN VITRO STUDY; MEASUREMENT; MUTAGENICITY; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; SMOKING; SUPERCRITICAL FLUID EXTRACTION; TOBACCO; TOXICITY TESTING; 3T3 CELL LINE; ADVERSE EFFECTS; ANALYSIS; ANIMAL; CHEMISTRY; COMPARATIVE STUDY; DRUG EFFECTS; FIBROBLAST; GENETICS; HUMAN; MOUSE; MUTAGEN TESTING; MUTAGENESIS; MUTATION; PATHOLOGY; PRODUCT SAFETY; RISK ASSESSMENT; SALMONELLA ENTERICA SEROVAR TYPHIMURIUM; SMOKE; SUPERCRITICAL FLUID CHROMATOGRAPHY; TOXICITY;

3T3 CELLS; ANIMALS; CHROMATOGRAPHY, SUPERCRITICAL FLUID; CONSUMER PRODUCT SAFETY; DNA, BACTERIAL; FIBROBLASTS; HUMANS; MICE; MUTAGENESIS; MUTAGENICITY TESTS; MUTATION; NICOTINE; NICOTINIC AGONISTS; RISK ASSESSMENT; SALMONELLA TYPHIMURIUM; SMOKE; SMOKING; TOBACCO; TOBACCO PRODUCTS;

EID: 84969674416     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2016.05.016     Document Type: Article

References (68)

1. Adam T., McAughey J., Mocker C., McGrath C., Zimmermann R. Influence of filter ventilation on the chemical composition of cigarette mainstream smoke. Anal. Chim. Acta 2010, 657:36-44.
2. Aztiria E.M., Sogayar M.C., Barrantes F.J. Expression of a neuronal nicotinic acetylcholine receptor in insect and mammalian host cell systems. Neurochem. Res. 2000, 25:171-180.
3. Bandiera F.C., Arguelles W., Gellman M., Castaneda S.F., Barnhart J., Gonzalez P., Navas-Nacher E.L., Salgado H., Talavera G.A., Schneiderman N., Lee D.J. Cigarette smoking and depressive symptoms among Hispanic/Latino adults: results from the Hispanic community health study/study of Latinos (HCHS/SOL). Nicotine Tob. Res. 2014, 10.1093/ntr/ntu209.
4. Banerjee J., Al-Wadei H.A., Schuller H.M. Chronic nicotine inhibits the therapeutic effects of gemcitabine on pancreatic cancer in vitro and in mouse xenografts. Eur. J. Cancer 2013, 49:1152-1158.
5. Benowitz N.L., Hall S.M., Stewart S., Wilson M., Dempsey D., Jacob P. Nicotine and carcinogen exposure with smoking of progressively reduced nicotine content cigarette. Cancer Epidemiol. Biomark. Prev. 2007, 16:2479-2485.
6. Benowitz N.L., Dains K.M., Hall S.M., Stewart S., Wilson M., Dempsey D., Jacob P. Smoking behavior and exposure to tobacco toxicants during 6 months of smoking progressively reduced nicotine content cigarettes. Cancer Epidemiol. Biomark. Prev. 2012, 21:761-769.
7. Bodnar J.A., Morgan W.T., Murphy P.A., Ogden M.W. Mainstream smoke chemistry analysis of samples from the 2009 US cigarette market. Regul. Toxicol. Pharmacol. 2012, 64:35-42.
8. Bombick D.W., Ayres P.H., Doolittle D.J. Cytotoxicity assessment of whole smoke and vapor phase of mainstream and sidestream cigarette smoke from three Kentucky reference cigarettes. Toxicol. Mech. Methods 1997, 7:177-190.
9. Brown K.C., Perry H.E., Lau J.K., Jones D.V., Pulliam J.F., Thornhill B.A., Crabtree C.M., Luo H., Chen Y.C., Dasgupta P. Nicotine induces the up-regulation of the alpha7-nicotinic receptor (alpha7-nAChR) in human squamous cell lung cancer cells via the Sp1/GATA protein pathway. J. Biol. Chem. 2013, 288:33049-33059.
10. Burns D.M., Dybing E., Gray N., Hecht S., Anderson C., Sanner T., O'Connor R., Djordjevic M., Dresler C., Hainaut P., Jarvis M., Opperhuizen A., Straif K. Mandated lowering of toxicants in cigarette smoke: a description of the World Health Organization TobReg proposal. Tob. Control 2008, 17:132-141.
11. Cardinale A., Nastrucci C., Cesario A., Russo P. Nicotine: specific role in angiogenesis, proliferation and apoptosis. Crit. Rev. Toxicol. 2012, 42:68-89.
12. Carmines E.L. Evaluation of the potential effects of ingredients added to cigarettes. Part 1: cigarette design, testing approach, and review of results. Food Chem. Toxicol. 2002, 40:77-91.
13. Catanzaro D.F., Zhou Y., Chen R., Yu F., Catanzaro S.E., De Lorenzo M.S., Subbaramaiah K., Zhou X.K., Pratico D., Dannenberg A.J., Weksler B.B. Potentially reduced exposure cigarettes accelerate atherosclerosis: evidence for the role of nicotine. Cardiovasc. Toxicol. 2007, 7:192-201.
14. Chen J., Higby R., Tian D., Tan D., Johnson M.D., Xiao Y., Kellar K.J., Feng S., Shields P.G. Toxicological analysis of low-nicotine and nicotine-free cigarettes. Toxicology 2008, 249:194-203.
15. Chen P.X., Moldoveanu S.C. Mainstream smoke chemical analyses for 2R4F Kentucky reference cigarette. Beitr. Tabakforsch. Int. 2003, 20:448-458.
16. Counts M.E., Hsu F.S., Tewes F.J. Development of a commercial cigarette "market map" comparison methodology for evaluating new or non-conventional cigarettes. Regul. Toxicol. Pharmacol. 2006, 46:225-242.
17. Cummins S. Adding very low nicotine content cigarettes to nicotine replacement therapy and behavioural support increases abstinence at 6 months after the quit date. Evid. Based Nurs. 2014, 17:19-20.
18. DeMarini D.M., Gudi R., Szkudlinska A., Rao M., Recio L., Kehl M., Kirby P.E., Polzin G., Richter P.A. Genotoxicity of 10 cigarette smoke condensates in four test systems: comparisons between assays and condensates. Mut. Res. 2008, 650:15-29.
19. Dermody S.S., Donny E.C., Hertsgaard L.A., Hatsukami D.K. Greater reductions in nicotine exposure while smoking very low nicotine content cigarettes predict smoking cessation. Tob. Control 2014, 10.1136/tobaccocontrol-2014-051797.
20. Diana J.N., Vaught A. Research Cigarettes 1990, University of Kentucky Printing Services, Lexington, KY.
21. Domino E.F., Ni L., Domino J.S., Yang W., Evans C., Guthrie S., Wang H., Koeppe R.A., Zubieta J.K. Denicotinized versus average nicotine tobacco cigarette smoking differentially releases striatal dopamine. Nicotine Tob. Res. 2013, 15:11-21.
22. Donny E.C., Denlinger R.L., Tidey J.W., Koopmeiners J.S., Benowitz N.L., Vandrey R.G., al'Absi M., Carmella S.G., Cinciripini P.M., Dermody S.S., Drobes D.J., Hecht S.S., Jensen J., Lane T., Le C.T., McClernon F.J., Montoya I.D., Murphy S.E., Robinson J.D., Stitzer M.L., Strasser A.A., Tindle H., Hatsukami D.K. Randomized trial of reduced-nicotine standards for cigarettes. N. Engl. J. Med. 2015, 373:1340-1349.
23. Fu X.W., Lindstrom J., Spindel E.R. Nicotine activates and up-regulates nicotinic acetylcholine receptors in bronchial epithelial cells. Am. J. Respir. Cell Mol. Biol. 2009, 41:93-99.
24. Gaworski C.L., Schramke H., Diekmann J., Meisgen T.J., Tewes F.J., Veltel D.J., Vanscheeuwijck P.M., Rajendran N., Muzzio M., Haussmann H.J. Effect of filtration by activated charcoal on the toxicological activity of cigarette mainstream smoke from experimental cigarettes. Inhal. Toxicol. 2009, 21:688-704.
25. Gaworski C.L., Oldham M.J., Wagner K.A., Coggins C.R., Patskan G.J. An evaluation of the toxicity of 95 ingredients added individually to experimental cigarettes: approach and methods. Inhal. Toxicol. 2011, 23(Suppl. 1):1-12.
26. Grando S.A. Connections of nicotine to cancer. Nat. Rev. Cancer 2014, 14:419-429.
27. Hatsukami D.K., Kotlyar M., Hertsgaard L.A., Zhang Y., Carmella S.G., Jensen J.A., Allen S.S., Shields P.G., Murphy S.E., Stepanov I., Hecht S.S. Reduced nicotine content cigarettes: effects on toxicant exposure, dependence and cessation. Addiction 2010, 105:343-355.
28. Hatsukami D.K., Benowitz N.L., Donny E., Henningfield J., Zeller M. Nicotine reduction: strategic research plan. Nicotine Tob. Res. 2013, 15:1003-1013.
29. Haussmann H.-J., Fariss M.W. Comprehensive review of epidemiological and animal studies on the potential carcinogenic effects of nicotine per se. Crit. Rev. Toxicol. 2016, 10.1080/10408444.2016.1182116.
30. Improgo M.R., Soll L.G., Tapper A.R., Gardner P.D. Nicotinic acetylcholine receptors mediate lung cancer growth. Front. Physiol. 2013, 4:251.
31. International Organization for Standardization ISO 10362-2. Cigarettes - Determination of Water in Smoke Condensates - Part 2. Karl Fischer Method 1994, International Organization for Standardization, Geneva.
32. International Organization for Standardization ISO 2971. Cigarettes and Filter Rods - Determination of Nominal Diameter - Methods Using a Laser Beam Measuring Apparatus 1998, International Organization for Standardization, Geneva.
33. International Organization for Standardization ISO 3402. Tobacco and Tobacco Products - Atmosphere for Conditioning and Testing 1999, International Organization for Standardization, Geneva.
34. International Organization for Standardization ISO 3308. Routine Analytical Cigarette-smoking Machine. Definitions and Standard Conditions 2000, International Standards Organization, Geneva.
35. International Organization for Standardization ISO 4387. Cigarettes - Determination of Total and Nicotine-free Dry Particulate Matter Using a Routine Analytical Smoking Machine 2000, International Organization for Standardization, Geneva.
36. International Organization for Standardization ISO 10315. Cigarettes - Determination of Nicotine in Smoke Condensates - Gas Chromatographic Method 2000, International Organization for Standardization, Geneva.
37. International Organization for Standardization ISO 9512. Cigarettes - Determination of Ventilation - Definitions and Measurement Principles 2002, International Organization for Standardization, Geneva.
38. International Organization for Standardization ISO 6565. Tobacco and Tobacco Products - Draw Resistance of Cigarettes and Pressure Drop of Filter Rods - Standard Conditions and Measurement 2005, International Organization for Standardization, Geneva.
39. International Organization for Standardization ISO 2965. Materials Used as Cigarette Papers, Filter Plug Wrap and Filter Joining Paper, Including Materials Having a Discrete or Oriented Permeable Zone and Materials with Bands of Differing Permeability - Determination of Air Permeability 2009, International Organization for Standardization, Geneva.
40. Lam D.C., Luo S.Y., Fu K.H., Lui M.M., Chan K.H., Wistuba I.I., Gao B., Tsao S.W., Ip M.S., Minna J.D. Nicotinic acetylcholine receptor expression in human airway correlates with lung function. Am. J. Physiol. Lung Cell Mol. Physiol. 2016, 310:L232-L239.
41. Life Sciences Research Office Review of Ingredients Added to Cigarettes. Phase Two: Scientific Criteria for the Evaluation of Ingredients Added to Cigarettes 2004, LSRO, Bethesda, MD.
42. Maneckjee R., Minna J.D. Opioids induce while nicotine suppresses apoptosis in human lung cancer cells. Cell Growth Differ. 1994, 5:1033-1040.
43. Marks M.J., Stitzel J.A., Collins A.C. Time course study of the effects of chronic nicotine infusion on drug response and brain receptors. J. Pharmacol. Exp. Ther. 1985, 235:619-628.
44. Maron D.M., Ames B.N. Revised methods for the Salmonella mutagenicity test. Mutat. Res. 1983, 113:173-215.
45. Morgan E.D. Supercritical Fluid Extraction 2000, (accessed 29-Dec-2015). https://www.thevespiary.org/library/Files_Uploaded_by_Users/Sedit/Chemical%20Analysis/Encyclopedia%20of%20Separation%20Science/Level%20III%20-%20Practical%20Applications/NATURAL%20PRODUCTS%20-%20Supercritical%20Fluid%20Extraction.pdf.
46. Naik P., Fofaria N., Prasad S., Sajja R.K., Weksler B., Couraud P.O., Romero I.A., Cucullo L. Oxidative and pro-inflammatory impact of regular and denicotinized cigarettes on blood brain barrier endothelial cells: is smoking reduced or nicotine-free products really safe?. BMC Neurosci. 2014, 15:51.
47. O'Connor R.J., Hammond D., McNeill A., King B., Kozlowski L.T., Giovino G.A., Cummings K.M. How do different cigarette design features influence the standard tar yields of popular cigarette brands sold in different countries?. Tob. Control 2008, 17(Suppl. 1):i1-i5.
48. Oldham M.J., Haussmann H.J., Gomm W., Rimmer L.T., Morton M.J., McKinney W.J. Discriminatory power of standard toxicity assays used to evaluate ingredients added to cigarettes. Regul. Toxicol. Pharmacol. 2012, 62:49-61.
49. Organisation for Economic Co-operation and Development No. 471. Bacterial Reverse Mutation Test 1997, OECD, Paris.
50. Organisation for Economic Co-operation and Development No. 432. In Vitro 3T3 NRU Phototoxicity Test 1997, OECD, Paris.
51. ®) with the 1R4F reference cigarette. Inhal. Toxicol. 2008, 20:695-721.
52. Piade J.J., Wajrock S., Jaccard G., Janeke G. Formation of mainstream cigarette smoke constituents prioritized by the World Health Organization-yield patterns observed in market surveys, clustering and inverse correlations. Food Chem. Toxicol. 2013, 55:329-347.
53. Prasad, R., Grubbs, H.J., 1996. Process and apparatus for the semicontinuous extraction of nicotine from tobacco. U.S. Patent No. 5,497,792. < (accessed 29-Dec-2015). http://www.google.com/patents/US5497792.
54. Putnam K.P., Bombick D.W., Doolittle D.J. Evaluation of eight in vitro assays for assessing the cytotoxicity of cigarette smoke condensate. Toxicol. In Vitro 2002, 16:599-607.
55. Rickert W.S., Trivedi A.H., Momin R.A., Wright W.G., Lauterbach J.H. Effect of smoking conditions and methods of collection on the mutagenicity and cytotoxicity of cigarette mainstream smoke. Toxicol. Sci. 2007, 96:285-293.
56. Roemer E., Tewes F.J., Meisgen T.J., Veltel D.J., Carmines E.L. Evaluation of the potential effects of ingredients added to cigarettes. Part 3: In vitro genotoxicity and cytotoxicity. Food Chem. Toxicol. 2002, 40:105-111.
57. Roemer E., Stabbert R., Rustemeier K., Veltel D.J., Meisgen T.J., Reininghaus W., Carchman R.A., Gaworski C.L., Podraza K.F. Chemical composition, cytotoxicity and mutagenicity of smoke from US commercial and reference cigarettes smoked under two sets of machine smoking conditions. Toxicology 2004, 195:31-52.
58. Roemer E., Dempsey R., Hirter J., Deger E.A., Weber S., Ode A., Wittke S., Schorp M.K. Toxicological assessment of kretek cigarettes Part 6: the impact of ingredients added to kretek cigarettes on smoke chemistry and in vitro toxicity. Regul. Toxicol. Pharmacol. 2014, 70(Suppl. 1):S66-S80.
59. Scherer G. Smoking behaviour and compensation: a review of the literature. Psychopharmacology (Berl) 1999, 145:1-20.
60. Shields P.G. Tobacco smoking, harm reduction, and biomarkers. J. Natl. Cancer Inst. 2002, 94:1435-1444.
61. Stephens W.E. Dependence of tar, nicotine and carbon monoxide yields on physical parameters: implications for exposure, emissions control and monitoring. Tob. Control 2007, 16:170-176.
62. Strasser A.A., O'Connor R.J., Mooney M.E., Wileyto E.P. Digital image analysis of cigarette filter stains as an indicator of compensatory smoking. Cancer Epidemiol. Biomark. Prev. 2006, 15:2565-2569.
63. Thun M.J., Henley S.J., Calle E.E. Tobacco use and cancer: an epidemiologic perspective for geneticists. Oncogene 2002, 21:7307-7325.
64. U.S.Department of Health and Human Services Good Laboratory Practice for Non-clinical Laboratory Studies 1996, 21 C.F.R. 58, (accessed 29-Dec-2015). http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58.
65. Ungar K. The INVITTOX data bank of in-vitro techniques in toxicology. Hum. Exp. Toxicol. 1992, 11:151-154.
66. US Food and Drug Administration Center for Tobacco Products Harmful and potentially harmful constituents in tobacco products and tobacco smoke: established list. Fed. Regist. 2012, 77:20034-20037.
67. Walker N., Fraser T., Howe C., Laugesen M., Truman P., Parag V., Glover M., Bullen C. Abrupt nicotine reduction as an endgame policy: a randomised trial. Tob. Control 2014, 10.1136/tobaccocontrol-2014-051801.
68. Warren G.W., Romano M.A., Kudrimoti M.R., Randall M.E., McGarry R.C., Singh A.K., Rangnekar V.M. Nicotinic modulation of therapeutic response in vitro and in vivo. Int. J. Cancer 2012, 131:2519-2527.